Integrity Products , St Louis MO is voluntarily recalling tainted lot (HGW221116) within expiry of the Ram It & To The Moon capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Ram It & To The Moon products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall.
Risk Statements: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening. The products affected are men with diabetes, high blood pressure, high cholesterol, or heart disease. To date, Integrity Products. has not received any reports of adverse events related to this recall.
The product is marketed as dietary supplements for male sexual enhancement and is packaged in a blister card. 10 count box. Ram It & To The Moon were distributed to consumers nationwide via the Internet. We are notifying the public through this public announcement due to lack of ability to identify customers who may have received the product. Integrity Products. is notifying its customers that have the Ram It & To The Moon products to stop use and properly discard the product.
Consumers with questions regarding this recall can contact Integrity Products. at integrityproductsusa@gmail.com, St Louis MO Monday – Friday 9am to 9pm Eastern Standard Time Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: download www.fda.gov/medwatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed from, or submit by fax 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S Food and Drug Administration.
